Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT07214766
Eligibility Criteria:
Inclusion Criteria:
* Within body mass index (BMI) range 18 to 38 kilogram per meter square (kg/m2), inclusive. Body weight \<=100 kg
* Left ventricular ejection fraction (LVEF) \>= 55 percent (%) measured by echocardiogram (ECHO)
* Negative test result for drugs of abuse
* Negative test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody screen
* Negative test for latent Tuberculosis (TB) infection by QuantiFERON® TB Gold
* Agree to use contraception and will refrain from sperm donation
Exclusion Criteria:
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, respiratory, gastrointestinal, immunological, neurological, or psychiatric disorder; acute infection; or other unstable medical disease
* History of moderate or severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
* Known sensitivity to recombinant hyaluronidase or other form of hyaluronidase
* History or presence of atrial fibrillation
* History of any clinically significant or clinically relevant cardiac condition
* History or presence of clinically significant electrocardiogram (ECG) abnormalities
* History of uncontrolled hypertension, hyperlipidemia, thyroid disorder, or diabetes
* Family history of clinically significant and clinically relevant hypersensitivity, allergy, or severe cardiac diseases
* History of previous anti-cancer treatments including pertuzumab, trastuzumab, anthracyclines, or any cardiotoxic drugs
* History of active or latent TB, regardless of treatment history
* Poor peripheral venous access
* History or presence of any malignancy, with the exception of completely excised basal cell or squamous cell carcinoma of the skin
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07214766
Study Brief:
Protocol Section:
NCT07214766